Digital Therapeutics for Behavior Problems
Reach and Scalability of Digital Therapeutics for Childhood Behavior Problems
2 other identifiers
interventional
324
1 country
1
Brief Summary
In this project, the investigators aim to test the effectiveness of a mobile health (mHealth) system as a standalone versus coach-assisted intervention with the goal of achieving reach and scalability. Parents of children (ages 5-8) with disruptive behaviors (N = 324 subjects) will be randomly assigned to Group 1 (standalone app), Group 2 (coach-assisted app), or Group 3 (control app).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 30, 2022
CompletedStudy Start
First participant enrolled
December 3, 2022
CompletedFirst Posted
Study publicly available on registry
December 12, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
September 23, 2025
September 1, 2025
3.8 years
November 30, 2022
September 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Knowledge of Effective Parenting Test (KEPT)
Average scores from the Knowledge of Effective Parenting Test (KEPT). This is a 21-item scale, with higher scores indicating better outcomes.
Post assessment (4 months after baseline).
Knowledge of Effective Parenting Test (KEPT)
Average scores from the Knowledge of Effective Parenting Test (KEPT). This is a 21-item scale, with higher scores indicating better outcomes.
6-month follow-up (10 months after baseline).
Secondary Outcomes (6)
Parenting Skill Use Diary (PSUD)
Post assessment (4 months after baseline).
Parenting Skill Use Diary (PSUD)
6-month follow-up (10 months after baseline).
Oppositional Defiant Disorder Subscale of the Vanderbilt Assessment
Post assessment (4 months after baseline).
Oppositional Defiant Disorder Subscale of the Vanderbilt Assessment
6-month follow-up (10 months after baseline).
Conduct Disorder Subscale of the Vanderbilt Assessment
Post assessment (4 months after baseline).
- +1 more secondary outcomes
Study Arms (3)
Group 1: Standalone App
EXPERIMENTALStandalone parenting app called UseIt!
Group 2: App plus Coach
EXPERIMENTALStandalone parenting app called UseIt! plus a coach.
Group 3: Control App
ACTIVE COMPARATORControl condition: mindfulness app called SmilingMind.
Interventions
The UseIt! app is a parenting app with evidence-based parent management content. The app runs on both Android and iOS devices. It includes a digital library of parent management skills, a trouble-shooting guide, a behavior diary, a point counter, and a skills-alarm.
The coach is be a bachelor's level paraprofessional with a degree in psychology or an allied discipline (e.g., social work) who provides support to parents. The coach will provide motivation and accountability but will not provide therapeutic/clinical support. The primary goal of the coach is to increase participant engagement with the UseIt! mHealth system.
The control app is a mindfulness app called SmilingMind. It is available for both Android and iOS devices.
Eligibility Criteria
You may qualify if:
- Males or females between the ages of 5-8 years
- Above the 90th percentile for Oppositional Defiant Disorder (ODD) and/or conduct disorders (CD) on the Vanderbilt Assessment Scale
- Residence with at least one parent/guardian at least 80% of the time
- Parent/legal guardian consent for participation
- Parent/guardian must have a smartphone device with daily internet access
You may not qualify if:
- A known preexisting behavioral or mental health diagnosis requiring alternative treatment (bipolar disorder, major depression, pervasive developmental disorder)
- Currently in treatment for childhood disruptive behavior
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bellefield Towers
Pittsburgh, Pennsylvania, 15213, United States
Related Publications (1)
Lindhiem O, Tomlinson CS, Kolko DJ, Silk JS, Hafeman D, Wallace M, Setiawan IMA, Parmanto B. Novel Smartphone App and Supportive Accountability for the Treatment of Childhood Disruptive Behavior Problems: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Mar 11;14:e67051. doi: 10.2196/67051.
PMID: 40068698DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Oliver Lindhiem, PhD
University of Pittsburgh, Department of Psychiatry
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 30, 2022
First Posted
December 12, 2022
Study Start
December 3, 2022
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
April 1, 2027
Last Updated
September 23, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Following publication of primary findings at the conclusion of the study.
- Access Criteria
- To gain access, anyone not part of the original research protocol will submit a Data Analysis Request Form which requires elucidation of hypotheses to be tested and specific data requested. This form requires information about the investigator, including institutional affiliation, resume, proposed research, and conflict of interest statement. The investigator must document completion of the University of Pittsburgh Certification Program in Research Practice Fundamentals or a comparable training program at their own institution. Investigators outside the University of Pittsburgh must also complete a Data Use and Confidentiality Agreement before release of data to them.
All data collected for this project will be made available to other researchers for future data mining, following publication of primary findings at the conclusion of the study. The investigators will share data with other investigators within and outside the University of Pittsburgh upon submission of a standardized written request. All data sharing will follow the guidelines and rules of the NIH and our IRB. Data (both raw data and summary scores) will be shared electronically (secure digital file) as de-identified data.